Arthrex® AR-9156-22PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867136595), received between Dec 16, 2019 and Dec 5, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2024Material Fragmentation; Material Fragmentation

  ON 11/07/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT HAD A SHOULDER SCOPE ARTHROPLASTY PROCEDURE COMPLETED SUCCESSFULLY THREE YEARS AGO. THE PATIENT REPORTED HAVING POST-SURGERY ADVERSE REACTIONS TO THE IMPLANT THAT WAS IMPLANTED. THE SURGEON PERFORMED A BIOPSY AND FOUND METALLOSIS IN THE JOINT. PHOTOS WERE TAKEN OF THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED ON 11/08/2024 VIA EMAIL: ON 11/04/2024, THE SURGEON BROUGHT ONE OF HIS PATIENTS BACK TO THE OPERATING ROOM FOR A BIOPSY AND DIAGNOSTIC ARTHROPLASTY TO SEE WHY, AFTER A SUCCESSFUL TSA OUTCOME, THE PATIENT HAD SUDDENLY EXPERIENCED A HIGH AMOUNT OF PAIN IN THE LAST 6 MONTHS. SHOTS AND CONSERVATIVE TREATMENTS FAILED, AND THE PATIENT WAS BROUGHT INTO THE OR FOR ARTHROSCOPIC EVALUATION. THE SURGEON FOUND SEVERE METALLOSIS IN THE JOINT (PHOTO ATTACHED). NO FAILURE OF IMPLANTS OR LOOSENESS COULD NOT BE DETERMINED AT THE TIME. THE SURGEON TOOK THE ARTHROSCOPIC BIOLOGICAL CULTURES AND SENT THEM TO THE LAB FOR ANALYSIS. THE ARTHREX PRODUCTS IMPLANTED IN THE INITIAL SURGERY WERE AR-9106-03 ARTHREX UNIVERS VAULTLOCK GLENOID, AR-9100-11S UNIVERS APEX HUMERAL STEM, AND AR-9156-22P ARTHREX UNIVERS II 3D HUMERAL

  Patient problems: Foreign Body Reaction

  MAUDE report 20854169 ↗
• InjuryDec 16, 2019Loose or Intermittent Connection

  IT WAS REPORTED VIA THE SURGICAL OUTCOME SYSTEM THAT A PATIENT IN THE ARTHREX SHOULDER ARTHROPLASTY STUDY HAD A RIGHT TOTAL SHOULDER ARTHROPLASTY PROCEDURE (B)(6) 2017. THE PATIENT WAS RECENTLY COMPLAINED OF PAIN AND WAS DIAGNOSED WITH LOOSENING OF THE HUMERAL PROSTHESIS. THE PATIENT UNDERWENT A REVISION PROCEDURE (B)(6) 2019 DURING WHICH ONLY THE HUMERAL COMPONENTS OF THE TOTAL SHOULDER ARTHROPLASTY WERE EXPLANTED. THE FOLLOWING ARTHREX DEVICES WERE EXPLANTED DURING THE 2019 PROCEDURE: AR-9156-22P HUMERAL HEAD (LOT 160084912) AND AR-9100-12S HUMERAL STEM (LOT 10064889). THE HUMERAL COMPONENTS WERE REPLACED WITH ANOTHER MANUFACTURERS PRODUCT. AT THIS TIME THE DISPOSITION OF THE EXPLANTED DEVICES IS UNKNOWN. ADDITIONAL INFORMATION OBTAINED 12/2/19: FACILITY HAS CONFIRMED THAT THE DEVICE IS NO LONGER AVAILABLE TO RETURN FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 9473265 ↗